How to reduce suffering and death from Prostate cancer. Lessons learned from the US

How to reduce suffering and death from Prostate cancer…. Lessons learned from the US Edward “Ted” Schaeffer MD PhD R. Christian B Evensen Professor of...
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How to reduce suffering and death from Prostate cancer…. Lessons learned from the US Edward “Ted” Schaeffer MD PhD R. Christian B Evensen Professor of Urology Director of the Prostate Cancer Program Johns Hopkins School of Medicine December 4, 2015

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New position •  Edmund Andrews Professor •  Chair of the Department of Urology •  Director of the Urologic Oncology Program at the Luire Comprehensive Cancer Center

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Disclosures •  No Relevant Financial Relationships to •  Disclose •  Non FDA Approved Use of Drugs and •  Products Referenced in this presentation •  -none December 4, 2015

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Contemporary approach in the US to reduce suffering and death from prostate cancer Improved treatment can occur at multiple levels of care •  Hospital level •  Physician level •  Patient level

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Prostate Cancer: Second leading cause of cancer related death in US men

From Jemal, A. et al. CA Cancer J Clin 2008;58:71-96. Copyright ©2008 American Cancer Society

Historical approach to reducing prostate cancer deaths Screen everyone + Treat everyone = Reduced prostate cancer deaths* *Caveat to this approach is significant overtreatment of the disease

Contemporary approach to reducing prostate cancer deaths Grade of the cancer Stage of the cancer PSA biomarker + Anticipated life expectancy = Treatment - Yes/No December 4, 2015

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From: Trends in Management for Patients With Localized Prostate Cancer, 1990-2013 JAMA. 2015;314(1):80-82. doi:10.1001/jama.2015.6036

Figure Legend: Treatment Trends for the Overall Cohort in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) RegistryError bars indicate 95% confidence intervals; CAPRA, Cancer of the Prostate Risk Assessment.

Date of download: 11/1/2015

Copyright © 2015 American Medical Association. All rights reserved.

Prostate Cancer: Second leading cause of cancer related death in men

From Jemal, A. et al. CA Cancer J Clin 2008;58:71-96. Copyright ©2008 American Cancer Society

Contemporary approach to reducing prostate cancer deaths Improved Prostate Cancer screening approaches = Henrik Gronberg

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Contemporary approach in the US to reduce suffering and death from prostate cancer Improved treatment can occur at multiple levels of care •  Hospital level •  Physician level •  Patient level

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Contemporary approach in the US to reduce suffering and death from prostate cancer Retrospective analyses reveals an organic approach to improve outcomes. •  Hospital level approaches –  Volume = Better outcome

•  Physician level approaches –  Volume = Better outcome

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•  >11,000 patients tracked through government billing codes •  Health related outcomes measured in relation to: –  Hospital volume –  Surgeon volume –  Volumes measures were determined by quartiles of Prostatectomies done/ 5 years –  Hospital volumes •  Low (< 8 cases/yr) High (> 29 cases/yr)

–  Surgeon Volumes •  Low (< 2.5 cases/yr) High (> 8 cases/yr)

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Health outcomes after prostate surgery •  Hospital –  No Difference in Death –  Post operative complications reduced in high volume hospitals –  Urinary complications reduced in high volume hospitals

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Health outcomes after prostate surgery •  Surgeon –  No Difference in Death –  Post operative complications reduced in high volume surgeons –  Urinary complications reduced in high volume surgeons

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Conclusions •  High volume hospitals and surgeons in the US were associated with improved: –  Recovery (fewer complications) –  Decreased long term complications

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Caveats to study… •  Early in the life of Radical Prostatectomy surgery •  Little granularity in the data •  High volume surgeons (>8 cases) and hospitals (>29 cases) relatively small volumes for the US. •  Did not evaluate cancer control •  Would even higher volume surgeons and hospitals do even better??? December 4, 2015

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Wilt systematic review •  17 studies on Volume and Outcome •  Hospitals with >43 surgeries/yr –  Lower mortality –  Lower morbidity

•  Surgeon Volume –  Decreased length of stay, complications –  Lower rates of incontinence/strictures –  Rates improves for each additional 10 cases December 4, 2015

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Conclusion #1 •  Multitude of retrospective data suggests hospitals and surgeons performing higher volume prostate procedures have improved outcomes.

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Conclusion #1 •  Multitude of retrospective data suggests hospitals and surgeons performing higher volume prostate procedures have improved outcomes. •  Patients should GET A SECOND OPINION! •  Institutions should publish their results December 4, 2015

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Patient resources •  Prostate Cancer Foundation of Norway •  http://prostatakreftstiftelsen.no

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http://prostatakreftstiftelsen.no/pcf_nor

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How have we proactively worked to improve patient outcomes •  Systematic case review –  Prostate Cancer Multidisciplinary Clinic

•  Systematic quality improvement

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Improved Identification of patients Prostate Cancer Multidisciplinary Clinic •  •  •  • 

200 patients / year Full day multi-specialty assessment Pathology and radiology re-review Multi-specialty assessment and plan

•  Since 2008 December 4, 2015

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Multi-Disciplinary Team •  •  •  •  • 

Urology Radiation Oncology Medical Oncology Radiology Pathology

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Pathology Gleason grade change in MDC

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Prostate Cancer Multidisciplinary Clinic

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Examples by “risk group”

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Summary of MDC clinic experience •  29% of men had a change in their stage and/or grade that potentially impacted treatment choices. –  6% of men with localized disease were found to have metastatic lesions

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Conclusion #2 •  MDC experience –  Time intensive; however, –  a systematic approach can improve patient care

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Improved treatment can occur at multiple levels of care •  Hospital level •  Physician level –  Systematic quality improvement

•  Patient level December 4, 2015

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Proactive quality tracking •  Surgeon specific, blinded outcome assessments

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Since Surgeons have no Ego… this has been easy!

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Hawthorn Effect •  Elton Mayo study on mechanisms to increase productivity (best lighting to maximize productivity) at a Western Electric plant (Hawthorn Works) in Cicero IL USA •  Productivity increased independent of lighting (high or low) •  Altered behavior in response to being observed

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Prostatectomy Report Card

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T2 Surgical Margin Rates - 2014.2 35 30 25 20 15

JHU 12.2

194X 6.5

10 5 0

T2 Surgical Rates - 2015.1 35 30 25 20 15 10

JHU 6.9

194X 4.7

5 0

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Conclusion #3 •  Proactive outcome tracking / safety dashboard –  Improved short term outcome measures. –  Long term functional recovery results are pending

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Improved treatment can occur at multiple levels of care •  Hospital level •  Physician level •  Patient level

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Can “precision medicine” also improve patient outcomes by reducing morbidity?

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Study Objective and Design •  Explore if genomic classifier could provide prognostic and predictive information regarding timing of post operative radiation in at risk cohort. •  Genomic Classifier – Decipher was performed on all men •  https://genomedx.com/

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Methods • 

Endpoint for the analysis was metastasis (regional or distant) as evidenced by positive CT and/or bone scans

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Adjuvant and salvage radiation treatment (RT) were defined by PSA levels of ≤ 0.2 and > 0.2 ng/mL prior to initiation of RT, respectively.

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Prognostic accuracy of the models were tested using c-index and decision curve analysis. Cox regression tested the relationship between GC and metastasis after adjusting for available covariates.

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Patients with high Genomic Classifier: Improved Mets free survival with ART vs SRT Patient with Low GC: No difference in met free survival Decipher  low-­‐risk  (GC  <  0.4)  

Decipher  high-­‐risk  (GC  ≥  0.4)  

Salvage RT

Adjuvant RT

Adjuvant RT

Salvage RT

HR Adjuvant RT (Ref Salvage RT)

Low Risk

0.76

95% CI

p value

0.11-5.46

0.787

HR Adjuvant RT (Ref Salvage RT)

High Risk

0.20

95% CI

p value

0.04-0.90

0.0357

•  80% reduction in hazards for high GC that got ART compared 48 to SRT

Conclusions •  Decipher test can help stratify men into risks groups where there may be potential benefit of ART vs SRT •  This may help guide physicians and patients deciding on ART vs SRT

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Conclusion - Final Contemporary approach in the US to reduce suffering and death from prostate cancer •  Hospital level •  Physician level •  Patient level

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Acknowledgements Schaeffer Lab Brian Simons Deb Sundi Farzana Faisel Michael Johnson JHMI Ashley Ross Paula Hurley George Netto Bruce Trock Angelo DeMarzo Helen Fedor December 4, 2015 Tamara Lotan

Felix Feng - UM Scott Tomlins -UM Jeff Karnes - Mayo 51

Thanks and Questions

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Genomic Classifier adds to predictive ability of individual pathologic features

04/12/15

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Cox MVA of Genomic Classifier and validated Nomograms

CAPRA-S**  

1.67 (1.54 - 1.82)  

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